Tissue grasping devices and related methods

ABSTRACT

A tissue gripping device is formed from a shape-memory material, and has a base section, a first arm, and a second arm disposed opposite the first arm, each arm having a first end coupled to the base section and a free end extending from the base section. The arms of the tissue gripping device are configured to resiliently flex toward a relaxed configuration in a distal direction as the tissue gripping device is moved from a pre-deployed configuration toward a deployed configuration. The tissue gripping device is usable in a method for gripping tissue. The method includes positioning the tissue gripping device near target tissue and moving the tissue gripping device from a pre-deployed configuration toward a deployed configuration in order to grip the target tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 16/883,382 filed on May 26, 2020, which is acontinuation application of U.S. patent application Ser. No. 14/805,275filed on Jul. 21, 2015, now U.S. Pat. No. 10,667,815, the contents ofwhich are hereby incorporated by reference in their entireties.

BACKGROUND

The present disclosure relates generally to medical methods, devices,and systems. In particular, the present disclosure relates to methods,devices, and systems for the endovascular, percutaneous, or minimallyinvasive surgical treatment of bodily tissues, such as tissueapproximation or valve repair. More particularly, the present disclosurerelates to repair of valves of the heart and venous valves, and devicesand methods for removing or disabling mitral valve repair componentsthrough minimally invasive procedures.

Surgical repair of bodily tissues often involves tissue approximationand fastening of such tissues in the approximated arrangement. Whenrepairing valves, tissue approximation often includes coapting theleaflets of the valves in a therapeutic arrangement which may then bemaintained by fastening or fixing the leaflets. Such fixation of theleaflets can be used to treat regurgitation which most commonly occursin the mitral valve.

Mitral valve regurgitation is characterized by retrograde flow from theleft ventricle of a heart through an incompetent mitral valve into theleft atrium. During a normal cycle of heart contraction (systole), themitral valve acts as a check valve to prevent flow of oxygenated bloodback into the left atrium. In this way, the oxygenated blood is pumpedinto the aorta through the aortic valve. Regurgitation of the valve cansignificantly decrease the pumping efficiency of the heart, placing thepatient at risk of severe, progressive heart failure.

Mitral valve regurgitation can result from a number of differentmechanical defects in the mitral valve or the left ventricular wall. Thevalve leaflets, the valve chordae which connect the leaflets to thepapillary muscles, the papillary muscles themselves, or the leftventricular wall may be damaged or otherwise dysfunctional. Commonly,the valve annulus may be damaged, dilated, or weakened, limiting theability of the mitral valve to close adequately against the highpressures of the left ventricle during systole.

The most common treatments for mitral valve regurgitation rely on valvereplacement or repair including leaflet and annulus remodeling, thelatter generally referred to as valve annuloplasty. One technique formitral valve repair which relies on suturing adjacent segments of theopposed valve leaflets together is referred to as the “bow-tie” or“edge-to-edge” technique. While all these techniques can be effective,they usually rely on open heart surgery where the patient's chest isopened, typically via a sternotomy, and the patient placed oncardiopulmonary bypass. The need to both open the chest and place thepatient on bypass is traumatic and has associated high mortality andmorbidity.

In some patients, a fixation device can be installed into the heartusing minimally invasive techniques. The fixation device can hold theadjacent segments of the opposed valve leaflets together to reducemitral valve regurgitation. One such device used to clip the anteriorand posterior leaflets of the mitral valve together is the MitraClip®fixation device, sold by Abbott Vascular, Santa Clara, Calif., USA.

These fixation devices often include clips designed to grip and holdagainst tissue as the clip arms are moved and positioned against thetissue at the treatment site and then closed against the tissue. Suchclips are designed to continue gripping the tissue as the fixationdevice is closed into a final position. In order to achieve this effect,such these clips are sometimes equipped with barbs or hooks to grip thetissue as the clip is flexed into position against the tissue.

However, some tissue fixation treatments require a fixation device tomove through a wide range of grasping angles in order to be properlypositioned relative to the target tissue and then to grasp the tissueand bring it to a closed position. This moving and plastically deformingcomponents of the fixation device during pre-deployment, positioning,and closure of the device can lead to the weakening and pre-maturedegradation of the fixation device. Additionally, some tissue fixationtreatments require that the fixation device maintain a degree offlexibility and mobility to allow a range of physiological movement evenafter the device has been properly placed and the target tissue has beenproperly fixed into the desired position, This can increase the risk ofpre-mature failure of the device as continued plastic deformation of theflexing components (e.g., from the continuous opening and closing ofvalve leaflets) leads to unfavorable degradation of the device.

For at least these reasons, there is an ongoing need to providealternative and/or additional methods, devices, and systems for tissuefixation that may provide beneficial elasticity and durability of theflexing components without unduly increasing the associatedmanufacturing costs of the flexing components. There is also a need toprovide such methods, devices, and systems in a manner that does notlimit the tissue gripping ability of the tissue fixation device. Atleast some of the embodiments disclosed below are directed toward theseobjectives.

BRIEF SUMMARY

At least one embodiment of the present disclosure relates to a tissuegripping device, the tissue gripping device including: a base section;and a first arm having a first end coupled to the base section, and afree end extending from the base section; wherein the base section andthe arm are formed of a shape-memory material configured to exhibitsuperelasticity in a physiological environment.

At least one embodiment of the present disclosure relates to a tissuefixation system configured for intravascular delivery and for use injoining mitral valve tissue during treatment of the mitral valve, thesystem including: a body; a first and second distal element, eachincluding a first end pivotally coupled to the body and extending to afree second end and a tissue engagement surface between the first andsecond end, the tissue engagement surface being configured toapproximate and engage a portion of leaflets of the mitral valve; and atissue gripping device formed of a shape-memory material, the tissuegripping device including a base section and a first arm and a secondarm, each arm having a first end coupled to the base section and a freeend extending from the base section, the first and second arms beingdisposed opposite one another and each arm being configured to cooperatewith one of the first or second distal elements to form a space forreceiving and holding a portion of mitral valve tissue therebetween.

At least one embodiment of the present disclosure relates to a method ofgripping tissue, the method including: positioning a tissue grippingdevice near a target tissue, the tissue gripping device being formedfrom a shape-memory material and including a base section and a firstarm and a second arm, each arm having a first end coupled to the basesection and a free end extending from the base section, the first andsecond arms being disposed opposite one another; and moving the tissuegripping device from a pre-deployed configuration toward a deployedconfiguration, the first and second arms being configured to resilientlyflex toward a relaxed configuration in a distal direction as the tissuegripping device is moved from a pre-deployed configuration toward adeployed configuration.

At least one embodiment of the present disclosure relates to a method ofmanufacturing a tissue gripping device, the method including: cuttingone or more structural features into a strip or sheet stock material ofa shape-memory alloy, the one or more structural features including aplurality of slotted recesses disposed at one or more side edges of thestock material; and heat shape setting one or more bend features intothe stock material.

At least one embodiment of the present disclosure relates to a tissuefixation kit, the kit including: a tissue gripping system that includesan actuator rod, an actuator line, a first and second distal element,each including a first end pivotally coupled to the actuator rod andextending to a free second end and a tissue engagement surface betweenthe first and second end, the first and second distal elements beingpositionable by the actuator rod, a tissue gripping device formed of ashape-memory material, the tissue gripping device including a basesection, a first arm, and a second arm, each arm having a first endcoupled to the base section and a free end extending from the basesection, the tissue gripping device being positionable by the actuatorline; a handle; and a delivery catheter having a proximal end and adistal end, the tissue gripping system being couplable to the distal endof the delivery catheter and the handle being couplable to the proximalend of the delivery catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent disclosure, a more particular description of the disclosure willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only illustrated embodiments of the disclosure and aretherefore not to be considered limiting of its scope. Embodiments of thedisclosure will be described and explained with additional specificityand detail through the use of the accompanying drawings in which:

FIG. 1 illustrates free edges of leaflets of the mitral valve in normalcoaptation, and

FIG. 2 illustrates the free edges in regurgitative coaptation;

FIGS. 3A-3C illustrate grasping of the leaflets with an embodiment of afixation assembly, inversion of the distal elements of the fixationassembly, and removal of the fixation assembly, respectively;

FIG. 4 illustrates the embodiment of a fixation assembly of FIGS. 3A-3Cin a desired orientation relative to the leaflets;

FIG. 5 illustrates an embodiment of a fixation assembly coupled to ashaft;

FIGS. 6A-6B, 7A-7C, and 8 illustrate an embodiment of a fixationassembly in various possible positions during introduction and placementof the assembly within the body to perform a therapeutic procedure;

FIGS. 9A-9C illustrate various views of an embodiment of a tissuegripping device according to the present disclosure;

FIGS. 10A-10C illustrate a prior art tissue fixation method;

FIGS. 11A-11C illustrate an embodiment of a tissue fixation method anddevice; and

FIGS. 12A-12C illustrate an embodiment of a method of manufacture of atissue gripping device.

DETAILED DESCRIPTION I. Cardiac Physiology

As shown in FIG. 1, the mitral valve (MV) consists of a pair of leaflets(LF) having free edges (FE) which, in patients with normal heartstructure and function, meet evenly to close along a line of coaption(C). The leaflets (LF) attach to the surrounding heart structure alongan annular region called the annulus (AN). The free edges (FE) of theleaflets (LF) are secured to the lower portions of the left ventricle LVthrough chordae tendinae (or “chordae”). As the left ventricle of aheart contracts (which is called “systole”), blood flow from the leftventricle to the left atrium through the mitral valve (MV) (called“mitral regurgitation”) is usually prevented by the mitral valve.Regurgitation occurs when the valve leaflets do not close properly andallow leakage from the left ventricle into the left atrium. A number ofheart structural defects can cause mitral regurgitation. FIG. 2 shows amitral valve with a defect causing regurgitation through a gap (G).

II. Exemplary Mitral Valve Fixation System

Several methods for repairing or replacing a defective mitral valveexist. Some defects in the mitral valve can be treated throughintravascular procedures, where interventional tools and devices areintroduced and removed from the heart through the blood vessels. Onemethod of repairing certain mitral valve defects includes intravasculardelivery of a fixation device to hold portions of the mitral valvetissues in a certain position. One or more interventional catheters maybe used to deliver a fixation device to the mitral valve and install itthere as an implant to treat mitral regurgitation.

FIG. 3A illustrates a schematic of an interventional tool 10 or a tissuefixation system with a delivery shaft 12 and a fixation device 14. Thetool 10 has approached the mitral valve MV from the atrial side andgrasped the leaflets LF. The fixation device 14 is releasably attachedto the shaft 12 of the interventional tool 10 at the distal end of theshaft 12. In this application, when describing devices, “proximal” meansthe direction toward the end of the device to be manipulated by the useroutside the patient's body, and “distal” means the direction toward theworking end of the device that is positioned at the treatment site andaway from the user. When describing the mitral valve, proximal means theatrial side of the leaflets and distal means the ventricular side of theleaflets. The fixation device 14 includes grippers 16 and distalelements 18 which protrude radially outward and are positionable onopposite sides of the leaflets LF as shown so as to capture or retainthe leaflets therebetween. The fixation device 14 is coupleable to theshaft 12 by a coupling mechanism 17.

FIG. 3B illustrates that the distal elements 18 may be moved in thedirection of arrows 40 to an inverted position. The grippers 16 may beraised as shown in FIG. 3C. In the inverted position, the device 14 maybe repositioned and then be reverted to a grasping position against theleaflets as in FIG. 3A. Or, the fixation device 14 may be withdrawn(indicated by arrow 42) from the leaflets as shown in FIG. 3C. Suchinversion reduces trauma to the leaflets and minimizes any entanglementof the device with surrounding tissues.

FIG. 4 illustrates the fixation device 14 in a desired orientation inrelation to the leaflets LF. The mitral valve MV is viewed from theatrial side, so the grippers 16 are shown in solid line and the distalelements 18 are shown in dashed line. The grippers 16 and distalelements 18 are positioned to be substantially perpendicular to the lineof coaptation C. During diastole (when blood is flowing from the leftatrium to the left ventricle), fixation device 14 holds the leaflets LFin position between the grippers 16 and distal elements 18 surrounded byopenings or orifices O which result from the diastolic pressuregradient, as shown in FIG. 4. Once the leaflets are coapted in thedesired arrangement, the fixation device 14 is detached from the shaft12 and left behind as an implant.

FIG. 5 illustrates an exemplary fixation device 14. The fixation device14 is shown coupled to a shaft 12 to form an interventional tool 10. Thefixation device 14 includes a coupling member 19, a gripper 16 having apair of opposed arms, and a pair of opposed distal elements 18. Thedistal elements 18 include elongate arms 53, each arm having a proximalend 52 rotatably connected to the coupling member 19 and a free end 54.Preferably, each free end 54 defines a curvature about two axes, axis 66perpendicular to longitudinal axis of elongate arms 53, and axis 67perpendicular to axis 66 or the longitudinal axis of elongate arms 53.Elongate arms 53 have tissue engagement surfaces 50. Elongate arms 53and tissue engagement surfaces 50 are configured to engage 4-10 mm oftissue, and preferably 6-8 mm, along the longitudinal axis of elongatearms 53. Elongate arms 53 further include a plurality of openings.

The arms of the gripper 16 are preferably resiliently biased toward thedistal elements 18. When the fixation device 14 is in the open position,each arm of the gripper 16 is separated from the engagement surface 50near the proximal end 52 of elongate arm 53 and slopes toward theengagement surface 50 near the free end 54 with the free end of thegripper 16 contacting engagement surface 50, as illustrated in FIG. 5.Arms of gripper 16 can include a plurality of openings 63 and scallopedside edges 61 to increase their grip on tissue. The arms of gripper 16optionally include a frictional element or multiple frictional elementsto assist in grasping the leaflets. The frictional elements may includebarbs 60 having tapering pointed tips extending toward tissue engagementsurfaces 50. Any suitable frictional elements may be used, such asprongs, windings, bands, barbs, grooves, channels, bumps, surfaceroughening, sintering, high-friction pads, coverings, coatings or acombination of these. The gripper 16 may be covered with a fabric orother flexible material. Preferably, when fabrics or coverings are usedin combination with barbs or other frictional features, such featureswill protrude through such fabric or other covering so as to contact anytissue engaged by gripper 16.

The fixation device 14 also includes an actuator or actuation mechanism58. The actuation mechanism 58 includes two link members or legs 68,each leg 68 having a first end 70 which is rotatably joined with one ofthe distal elements 18 at a riveted joint 76 and a second end 72 whichis rotatably joined with a stud 74. The actuation mechanism 58 includestwo legs 68 which are each movably coupled to a base 69. Or, each leg 68may be individually attached to the stud 74 by a separate rivet or pin.The stud 74 is joinable with an actuator rod which extends through theshaft 12 and is axially extendable and retractable to move the stud 74and therefore the legs 68 which rotate the distal elements 18 betweenclosed, open, and inverted positions. Immobilization of the stud 74holds the legs 68 in place and therefore holds the distal elements 18 ina desired position. The stud 74 may also be locked in place by a lockingfeature. This actuator rod and stud assembly may be considered a firstmeans for selectively moving the distal elements between a firstposition in which the distal elements are in a collapsed, low profileconfiguration for delivery of the device, a second position in which thedistal elements are in an expanded configuration for positioning thedevice relative to the mitral valve, and a third position in which thedistal elements are secured in position against a portion of theleaflets adjacent the mitral valve on the ventricular side.

FIGS. 6A-6B, 7A-7C, and 8 illustrate various possible positions of thefixation device 14 of FIG. 5. FIG. 6A illustrates an interventional tool10 delivered through a catheter 86. The catheter 86 may take the form ofa guide catheter or sheath. The interventional tool 10 comprises afixation device 14 coupled to a shaft 12 and the fixation device 14 isshown in the closed position.

FIG. 6B illustrates a device similar to the device of FIG. 6A in alarger view. In the closed position, the opposed pair of distal elements18 are positioned so that the tissue engagement surfaces 50 face eachother. Each distal element 18 comprises an elongate arm 53 having acupped or concave shape so that together the elongate arms 53 surroundthe shaft 12. This provides a low profile for the fixation device 14.

FIGS. 7A-7B illustrate the fixation device 14 in the open position. Inthe open position, the distal elements 18 are rotated so that the tissueengagement surfaces 50 face a first direction. Distal advancement of theactuator rod relative to shaft 12, and thus distal advancement of thestud 74 relative to coupling member 19, applies force to the distalelements 18 which begin to rotate around joints 76. Such rotation andmovement of the distal elements 18 radially outward causes rotation ofthe legs 68 about joints 80 so that the legs 68 are directed slightlyoutwards. The stud 74 may be advanced to any desired distancecorrelating to a desired separation of the distal elements 18. In theopen position, tissue engagement surfaces 50 are disposed at an acuteangle relative to shaft 12, and can be at an angle of between 15 and 270degrees relative to each other, preferably at an angle of between 45 and225 degrees or between 90 and 180 degrees relative to each other (e.g.,between 45 and 210 degrees, between 60 and 180 degrees, between 75 and165 degrees, between 90 and 150 degrees, between 115 and 135 degrees, or120 degrees). In the open position, the free ends 54 of elongate arms 53may have a span therebetween of 1-40 mm, or 5-30 mm, usually 10-20 mm or12-18 mm, and preferably 14-16 mm.

The arms of gripper 16 are typically biased outwardly toward elongatearms 53 when in a relaxed configuration. The arms of gripper 16 may bemoved inwardly toward the shaft 12 and held against the shaft 12 withthe aid of gripper lines 90 which can be in the form of sutures, wires,nitinol wire, rods, cables, polymeric lines, or other suitablestructures. The gripper lines 90 can extend through a shaft of adelivery catheter (not shown) and connect with the gripper 16. The armsof the gripper 16 can be raised and/or lowered by manipulation of thegripper lines 90. For example, FIG. 7C illustrates gripper 16 in alowered position as a result of releasing tension and/or providing slackto gripper lines 90. Once the device is properly positioned anddeployed, the gripper lines can be removed by withdrawing them throughthe catheter and out the proximal end of the tool 10. The gripper lines90 may be considered a second means for selectively moving the gripper16 between a first position in which the gripper arms are in acollapsed, low profile configuration for delivery of the device and asecond position in which the gripper arms are in an expandedconfiguration for engaging a portion of the leaflets adjacent the mitralvalve on the atrial side.

In the open position, the fixation device 14 can engage the tissue whichis to be approximated or treated. The interventional tool 10 is advancedthrough the mitral valve from the left atrium to the left ventricle. Thedistal elements 18 are then deployed by advancing actuator rod relativeto shaft 12 to thereby reorient distal elements 18 to be perpendicularto the line of coaptation. The entire assembly is then withdrawnproximally and positioned so that the tissue engagement surfaces 50contact the ventricular surface of the valve leaflets, thereby engagingthe left ventricle side surfaces of the leaflets. The arms of thegripper 16 remain on the atrial side of the valve leaflets so that theleaflets lie between the proximal and distal elements. Theinterventional tool 10 may be repeatedly manipulated to reposition thefixation device 14 so that the leaflets are properly contacted orgrasped at a desired location. Repositioning is achieved with thefixation device in the open position. In some instances, regurgitationmay also be checked while the device 14 is in the open position. Ifregurgitation is not satisfactorily reduced, the device may berepositioned and regurgitation checked again until the desired resultsare achieved.

It may also be desired to invert distal elements 18 of the fixationdevice 14 to aid in repositioning or removal of the fixation device 14.FIG. 8 illustrates the fixation device 14 in the inverted position. Byfurther advancement of actuator rod relative to shaft 12, and thus stud74 relative to coupling member 19, the distal elements 18 are furtherrotated so that the tissue engagement surfaces 50 face outwardly andfree ends 54 point distally, with each elongate arm 53 forming an obtuseangle relative to shaft 12.

The angle between elongate arms 53 when the device is inverted ispreferably in the range of 180 to 360 degrees (e.g., 210 to 360 degrees,240 to 360 degrees, 270 to 360 degrees, 300 to 360 degrees, or 330 to360 degrees). Further advancement of the stud 74 further rotates thedistal elements 18 around joints 76. This rotation and movement of thedistal elements 18 radially outward causes rotation of the legs 68 aboutjoints 80 so that the legs 68 are returned toward their initialposition, generally parallel to each other. The stud 74 may be advancedto any desired distance correlating to a desired inversion of the distalelements 18. Preferably, in the fully inverted position, the spanbetween free ends 54 is no more than 40 mm, or no more than 30 mm or 20mm, usually less than 16 mm, preferably 1-15 mm, 5-15 mm, or 10-15 mm,more preferably 12-14 mm. Barbs 60 are preferably angled in the distaldirection (away from the free ends of the grippers 16), reducing therisk that the barbs will catch on or lacerate tissue as the fixationdevice is withdrawn.

Once the distal elements 18 of the fixation device 14 have beenpositioned in a desired location against the ventricle side surfaces ofthe valve leaflets, the leaflets may then be captured between thegripper 16 and the distal elements 18. The arms of the gripper 16 arelowered toward the tissue engagement surfaces 50 by releasing tensionfrom gripper lines 90, thereby releasing the arms of the gripper 16 sothat they are then free to move, in response to the internal spring biasforce formed into gripper 16, from a constrained, collapsed position toan expanded, deployed position with the purpose of holding the leafletsbetween the gripper 16 and the distal elements 18. If regurgitation isnot sufficiently reduced and/or if one or more of the leaflets are notproperly engaged, the arms of the gripper 16 may be raised and thedistal elements 18 adjusted or inverted to reposition the fixationdevice 14.

After the leaflets have been captured between the gripper 16 and distalelements 18 in a desired arrangement, the distal elements 18 may belocked to hold the leaflets in this position or the fixation device 14may be returned to or toward a closed position. This is achieved byretraction of the stud 74 proximally relative to coupling member 19 sothat the legs 68 of the actuation mechanism 58 apply an upwards force tothe distal elements 18, which, in turn, rotate the distal elements 18 sothat the tissue engagement surfaces 50 again face one another. Thereleased grippers 16 which are biased outwardly toward distal elements18 are concurrently urged inwardly by the distal elements 18. Thefixation device 14 may then be locked to hold the leaflets in thisclosed position. The fixation device 14 may then be released from theshaft 12.

The fixation device 14 optionally includes a locking mechanism forlocking the device 14 in a particular position, such as an open, closed,or inverted position, or any position therebetween. The lockingmechanism may include a release harness. Applying tension to the releaseharness may unlock the locking mechanism. Lock lines can engage arelease harnesses of the locking mechanism to lock and unlock thelocking mechanism. The lock lines can extend through a shaft of thedelivery catheter. A handle attached to the proximal end of the shaftcan be used to manipulate and decouple the fixation device 14.

Additional disclosure regarding such fixation devices 14 may be found inPCT Publication No. WO 2004/103162 and U.S. patent application Ser. No.14/216,787, the disclosures of both of which are incorporated byreference herein in their entirety.

III. Improved Gripping Device

Certain embodiments of tissue fixation devices of the present disclosureinclude a gripper formed from a shape-memory material. In preferredembodiments, the shape-memory material is configured to exhibitsuperelasticity when positioned in a physiological environment. Suchshape-memory materials can include shape-memory alloys and/orshape-memory polymers. Shape-memory alloys included in embodiments ofgrippers of the present disclosure include copper-zinc-aluminum;copper-aluminum-nickel; nickel-titanium (NiTi) alloys known as nitinol;nickel-titanium platinum; and nickel-titanium palladium alloys, forexample. Shape-memory polymers included in embodiments of grippers ofthe present disclosure include biodegradable polymers, such asoligo(ε-caprolactone)diol, oligo(ρ-dioxanone)diol, and non-biodegradablepolymers such as, polynorborene, polyisoprene, styrene butadiene,polyurethane-based materials, vinyl acetate-polyester-based compounds,for example. In preferred embodiments, the gripper is formed fromnitinol. Such nitinol grippers can be configured with linear elasticproperties, non-linear elastic properties, pseudo linear-elasticproperties, or other elastic properties.

FIGS. 9A-9C illustrate various views of an embodiment of a tissuegripper 116 formed from a shape-memory material. In preferredembodiments, the tissue gripper 116 is formed from a nickel titaniumalloy with transformation temperature (e.g., an austenite finishtemperature (A_(f))) of −5 to 37 degrees C., or from −5 to 30 degreesC., or from −5 to 27 degrees C., or from −5 to 25 degrees C., or from −5to 20 degrees C., or from −5 to 15 degrees C., or from −5 to 10 degreesC., or from 0 to 10 degrees C. In such embodiments, the gripper 116 canexhibit superelasticity at physiological temperatures, and can exhibitsuperelasticity during flexing, bending, and/or other maneuvering of thegripper 116. For instance, the gripper 116 can exhibit superelasticityduring positioning and deployment of the device at a treatment siteand/or during continued movement after being deployed.

During a mitral valve repair procedure or other tissue fixing procedure,for example, portions of the tissue gripping device may need torepeatedly pass through wide angles as multiple tissue grasping attemptsare made and/or as the gripper 116 is moved into an acceptable positionagainst the leaflets of the mitral valve or against other targetedtissue. Furthermore, even after deployment, the tissue gripper 116 mayneed to provide some amount of flexibility and movement as the repairedand/or fixated tissue continues to flex and/or move. For example, onesituation where additional flexibility and movement may be necessary iswhere mitral valve tissue continues to flex against the gripper 116during cardiac cycles. In other situations, additional flexibility andmovement may be necessary as the repaired and/or fixated tissue flexes,shifts, stretches, or otherwise moves relative to an original fixedposition, such as with various musculoskeletal tissues during variousforms of physiological movement (e.g., in response to muscle contractionand/or relaxation, movement at a joint, and movement between adjacent ornearby connective tissues).

Forming the tissue gripper 116 from a shape-memory material such asnitinol may avoid plastic deformation of the tissue gripper 116 duringthese movements. In preferred embodiments, the shape-memory material isconfigured to exhibit superelasticity at physiological temperatures,thereby enabling the tissue gripper 116 to stay entirely within theelastic deformation range throughout its life within the body. Even morepreferably, the shape-memory material is configured to exhibitsuperelasticity throughout the range of temperatures expected to beencountered during pre-deployment, deployment, and implanted use withinthe body (e.g., 0 to 40 degrees C., 5 to 40 degrees C., 10 to 37 degreesC., 15 to 37 degrees C., 20 to 37 degrees C., and 22 to 37 degrees C.).

For instance, in some embodiments, the shape-memory material can benitinol, and the nitinol can be configured to have a hysteresis curvethat leaves the tissue gripper 116 within the elastic deformation rangethroughout its life and throughout the range of temperatures that areexpected to be encountered during pre-deployment, deployment, andimplanted use within the body, or during any other time where the tissuegripper 116 is flexed and/or deformed, such as during post manufacturingtesting and/or positioning within a delivery system prior to delivery totarget tissue. Such embodiments can advantageously reduce and/oreliminate mechanical fatigue and degradation of the tissue gripper 116from repeated and/or high levels of plastic deformation. In addition, aswill be explained in more detail below, embodiments of the presentdisclosure can promote easier tissue grasping during deployment and/orpositioning of the tissue gripper 116.

In the illustrated embodiment, the tissue gripper 116 includes aproximal side 114, a distal side 134, a base section 104, and a pair ofarms 106. Each arm 106 may extend from the base section 104 to a freeend 108. In other embodiments, there may be one arm extending from abase section, or there may be more than two arms extending from a basesection. For example, some embodiments may have multiple arms arrayedabout a base section (e.g., in a radial fashion), and/or may include afirst plurality of arms disposed opposite a second plurality of arms.

The gripper 116 of the illustrated embodiment includes a pair of basebend features 110 disposed at the base section 104, and a pair of armbend features 112 partitioning the arms 106 from the base section 104.The base bend features 110 form angles of 90 degrees or just under 90degrees (e.g., 15 to 165 degrees, 30 to 150 degrees, 45 to 135 degrees,60 to 120 degrees, 70 to 110 degrees, or 80 to 100 degrees) as measuredfrom the proximal side 114, and the arm bend features 112 form angles of90 degrees or just under 90 degrees (e.g., 15 to 165 degrees, 30 to 150degrees, 45 to 135 degrees, 60 to 120 degrees, 70 to 110 degrees, or 80to 100 degrees) as measured from the distal side 134.

The base bend features 110 and arm bend features 112 are configured togive the tissue gripper 116 a bent configuration when the tissue gripper116 is in a relaxed state, such that when the tissue gripper 116 isforced into a stressed state (e.g., by bending the tissue gripper 116 atone or more of the base and/or arm bend features 110 and 112), thetissue gripper 116 is resiliently biased toward the relaxed state.

For example, an arm 106 may be positioned at the arm bend feature 112 ina manner that flexes the arm 106 in a proximal direction and an inwarddirection, thereby flexing the arm 106 toward a straighter configuration(e.g., increasing the angle of the arm bend feature 112 as measured fromthe distal side 134). In such a position, the tissue gripper 116 is in astressed state such that the arm 106 of the tissue gripper 116 isresiliently biased toward a distal direction and an outward direction.Other embodiments may omit one or more of the bend features, and otherembodiments may include additional bend features. These and otherembodiments may include bend features with differing bend angles when ina relaxed state. For example, some embodiments may include bend featuresthat measure greater than 90 degrees or less than 90 degrees when in arelaxed state.

In another example, prior to moving the tissue gripper 116 into positionin the mitral valve or into position near other targeted tissue, thetissue gripper may be positioned in a pre-deployed configuration (see,e.g., FIGS. 6A-7B and related discussion) by positioning the arm bendfeatures 112 toward a straighter configuration. The tissue grippers ofthe present disclosure, such as illustrated tissue gripper 116,beneficially and advantageously can be moved into such a pre-deployedconfiguration without being plastically deformed at the arm bendfeatures 112 and/or at other areas. Accordingly, tissue gripper 116 maymove from such a pre-deployed configuration back toward a relaxedconfiguration by allowing the arms 106 to move distally and outwardly.In preferred embodiments, the relaxed configuration, after the tissuegripper 116 has been moved into a pre-deployed configuration and back,is the same or substantially the same as prior to the tissue gripper 116being moved into the pre-deployed configuration and back (e.g., theangles at the arm bend features 112 in the relaxed configuration areunchanged, as opposed to being altered as a result of plasticdeformation).

The tissue gripper 116 of the illustrated embodiment may include aplurality of holes 118 distributed along the length of each arm 106. Theholes 118 may be configured to provide a passage or tie point for one ormore sutures, wires, nitinol wires, rods, cables, polymeric lines, othersuch structures, or combinations thereof. As discussed above, thesematerials may be coupled to one or more arms 106 to operate as gripperlines (e.g., gripper lines 90 illustrated in FIGS. 7A-7C) for raising,lowering, and otherwise manipulating, positioning and/or deploying thetissue gripper 116. In some embodiments, for example, suture loops orother structures may be positioned at one or more of the holes 118, andone or more gripper lines may be threaded, laced, or otherwise passedthrough the suture loops. Such suture loops or other suture fasteningstructures may be wrapped and/or threaded a single time or multipletimes before being tied, tightened, or otherwise set in place. Forexample, some suture lines may be wrapped repeatedly and/or may doubleback on themselves in order to strengthen or further secure the couplingof the suture loop to an arm 106.

Other embodiments may include a tissue gripper with more or less holesand/or with holes in other positions of the tissue gripper. For example,some embodiments may omit holes completely, and some embodiments mayinclude only one hole and/or only one hole per arm. Other embodimentsmay include holes of different shapes and/or sizes, such as holes formedas slots, slits, or other shapes. In embodiments where more than onehole is included, the holes may be uniform in size, shape, anddistribution or may be non-uniform in one or more of size, shape, anddistribution.

Each arm 106 of the illustrated embodiment includes a furcated section120. The furcated section 120 may extend from the base section 104 to aposition farther along the arm 106 toward the free end 108 of the arm106, as illustrated. In other embodiments, a furcated section may bepositioned at other locations along an arm and/or base section. Otherembodiments may include one or more furcated sections extendingcompletely to the free end of an arm, thereby forming a bifurcated orfork-shaped arm. Other embodiments omit any furcated sections. Thefurcated sections 120 of the illustrated embodiment coincide with thearm bend features 112. The furcated sections 120 may be configured(e.g., in size, shape, spacing, position, etc.) so as to provide desiredresiliency, fatigue resistance, and/or flexibility at the coinciding armbend features 112.

As illustrated, the tissue gripper 116 includes a plurality offrictional elements 128 configured to engage with tissue at a treatmentsite and resist movement of tissue away from the tissue gripping memberafter the frictional elements 128 have engaged with the tissue. As shownin the illustrated embodiment, the frictional elements 128 are formed asangled barbs extending distally and inwardly from a side edge 130 of thearms 106 of the gripper 116. In this manner, tissue that is engaged withthe frictional elements 128 of a tissue gripper 116 is prevented frommoving proximally and outwardly relative to the tissue gripper 116.

The frictional elements 128 of the illustrated tissue gripper 116protrude from a side edge 130 of each of the arms 106, thereby forming aplurality of slotted recesses 132 disposed along side edges 130 of eacharm 106 at sections adjacent to the frictional elements 128. Otherembodiments may include frictional elements of varying size, number,and/or shape. For example, in some embodiments the frictional elementsmay be formed as posts, tines, prongs, bands, grooves, channels, bumps,pads, or a combination of these or any other feature suitable forincreasing friction and/or gripping of contacted tissue.

Embodiments of the devices, systems, and methods of the presentdisclosure can provide particular advantages and benefits in relation toa tissue gripping and/or tissue fixation procedure. For example, atleast one embodiment of the devices, systems, and methods of the presentdisclosure can include moving and/or flexing a tissue gripper from apre-deployed configuration toward a deployed configuration at a widerangle (e.g., angle in which the arms of the gripping device areseparated) than that disclosed by the prior art, providing advantagessuch as better grasping ability, less tissue trauma, better grasping ofseparate portions of tissue simultaneously (e.g., opposing leaflets ofthe mitral valve), reduced slip-out of tissue during additional devicemovements or procedural steps (e.g., during a closing step), reducedgrasping force required in order to grip the targeted tissue, orcombinations thereof. In addition, tissue grippers of the presentdisclosure may be moved into a pre-deployed configuration withoutresulting plastic deformation affecting the range of grasping angles ofthe device.

In addition, at least one embodiment of the present disclosure caninclude increased resistance to mechanical fatigue than that disclosedby the prior art. For example, at least some of the tissue grippingdevices of the present disclosure can be formed of a shape-memorymaterial that provides resistance to progressive weakening of the deviceas a result of repeatedly applied and/or cyclic loads. For instance, ascompared to a tissue gripping device not formed from a shape-memorymaterial, at least some of the tissue gripping devices of the presentdisclosure have enhanced resistance to the formation of microscopiccracks and other stress concentrators (e.g., at grain boundaries orother discontinuity locations of the material).

FIGS. 10A-10C illustrate a prior art gripping system 200 in use in atissue gripping application. FIG. 10A shows a tissue gripper 290 madefrom a plastically deformable material positioned in a pre-deployedconfiguration. A pair of distal elements 280 is illustrated in an openposition at 120 degrees, as measured from a proximal side, the pair ofdistal elements being positioned near target tissue 270 on the distalside of target tissue. Upon movement or release of the tissue gripper290 from the pre-deployment configuration, the arms of the tissuegripper 290 move slightly in a proximal and outward direction toward thetarget tissue 270. However, the tissue gripper 290 is only able to reacha deployment angle, as measured by the separation of the opposing armsof the tissue gripper 290 on the proximal side, of 85 degrees. Asillustrated in FIG. 10B, this may result in incomplete or missedgrasping of the target tissue 270, as the arms of the tissue gripper 290are unable to flex or extend outwardly and proximally far enough tofully engage with the target tissue 270.

As illustrated in FIG. 10C, gripping of the target tissue 270 requiresat least an additional step of closing the distal elements 280 to 60degrees in order to grip the target tissue 270 between the distalelements 280 and the arms of the tissue gripper 290 by moving the distalelements 280 proximally and inwardly toward the tissue gripper 290.During this step and/or during the interim between the positionillustrated in FIG. 10B and the position illustrated in FIG. 10C, thetarget tissue 270 may move or slip away from the gripping system 200. Inaddition, the position of the target tissue 270 or portions of thetarget tissue 270 may shift relative to the tissue gripper 290 and/orthe distal elements 280, requiring repositioning of the gripping system200 and/or its components. This can be particularly problematic inprocedures, such as mitral valve repair procedures, where the targettissue is rapidly and continuously moving, where multiple portions oftarget tissue must be grasped simultaneously, and where precise grippingposition is demanded. Such limitations limit the number of availabletissue gripping and/or fixation procedures and their effectiveness.

In contrast, FIGS. 11A-11C illustrate an embodiment of a tissue grippingsystem 300 of the present disclosure in a tissue gripping application.As illustrated in FIG. 11A, a pair of distal elements 318 are coupled toa body 336 (e.g., an actuator rod) and are associated with a tissuegripper 316. The tissue gripping system 300 may be positioned at or neartarget tissue 370, where the tissue gripper 316 can be positioned in apre-deployed configuration with the arms of the tissue gripper 316extending proximally from the base of the tissue gripper 316. Inaddition, the distal elements 318 may be moved to a distal side of thetarget tissue before, during, or after being positioned in an openconfiguration with an opening angle 340 of 120 degrees (e.g., 60 to 180degrees, 75 to 165 degrees, 90 to 150 degrees, 105 to 135 degrees, 100to 140 degrees, or 110 to 130 degrees). In other embodiments, theopening angle 340 may be more or less than 120 degrees (e.g., 60 to 90degrees, or 90 to 120 degrees, or 120 to 150 degrees, or 150 to 180degrees), though in preferred embodiments, the opening angle 340 is atleast 120 degrees or more (e.g., 120 to 180 degrees). In someembodiments, the opening angle 340 can be more than 180 degrees (e.g.,190 degrees or 200 degrees or more).

As illustrated in FIG. 11B, after positioning the distal elements 318,the tissue gripper 316 can be moved and/or dropped from the pre-deployedconfiguration, where the arms of the tissue gripper 316 are positionedin a stressed state, toward a deployed configuration, where the armsflex and/or move toward a relaxed state. The tissue gripper 316 may bemoved, dropped, or otherwise actuated using, for example, one or moregripper lines (such as those illustrated in FIGS. 7A-7C).

As illustrated in FIG. 11B, upon actuation, the tissue gripper 316 movesoutwardly and distally to fully engage with the target tissue 370, andto fully engage the target tissue 370 against the proximal surface ofthe distal elements 318 by closing to an actuation angle 342 (asmeasured from the proximal side) that is substantially similar to theopening angle 340 of the distal elements 318. For example, the actuationangle 342 may equal the opening angle 340 or may be slightly smallerthan the opening angle 340 (e.g., by 1 to 30 degrees, or 1 to 20degrees, or 1 to 10 degrees, or 1 to 5 degrees or less) as a result oftarget tissue 370 being gripped between the distal elements 318 and thearms of the tissue gripper 316.

As shown by FIG. 11B, the full length of the arms of the tissue gripper316 may be engaged against the target tissue 370 upon actuation of thetissue gripper 316 towards the deployed configuration. For example,because the actuation angle 342 is the same as or is substantiallysimilar to the opening angle 340, any separation between the proximalsurfaces of the distal elements 318 and the arms of the tissue gripper316 is due to an amount of target tissue 370 caught and/or engagedbetween the arms of the tissue gripper 316 and a proximal surface of adistal element 318.

The tissue gripper 316 can be configured to provide an actuation angle342 that is 90 to 180 degrees. In preferred embodiments, the actuationangle is 120 degrees (e.g., 60 to 180 degrees, 75 to 165 degrees, 90 to150 degrees, 105 to 135 degrees, 100 to 140 degrees, or 110 to 130degrees). In other embodiments, the actuation angle 342 may be more orless than 120 degrees (e.g., 60 to 90 degrees, or 90 to 120 degrees, or120 to 150 degrees, or 150 to 180 degrees).

In preferred embodiments, the tissue gripper 316 is configured such thatthe arms of the tissue gripper 316 resiliently flex against targettissue 370 and/or distal elements 318 after moving from a pre-deployedconfiguration toward a deployed configuration. For example, the tissuegripper 316 can be configured such that, when positioned in a relaxedconfiguration, the arms of the tissue gripper 316 are open at an anglethat is greater than a selected opening angle 340 of the distal elements318. In some embodiments, for example, the arms of the tissue gripper316, while positioned in a relaxed configuration, can be angled apart,as measured from a proximal side, at 180 degrees or slightly more than180 degrees (e.g., 190 to 200 degrees). In such embodiments, the openingangle 340 of the distal elements 318 can be less than the angle betweenthe arms of the tissue gripper 316 (e.g., 60 to 180 degrees, or 90 to150 degrees, or 120 degrees). For example, when the opening angle 340 is120 degrees, the actuation angle 344 of the tissue gripper 316 willexpand to reach 120 degrees or beyond 120 degrees after moving toward adeployed configuration, but the arms of the tissue gripper 316 will nothave moved to the full extent of the relaxed configuration. Thus, thearms of the tissue gripper 316, in such embodiments, will continue toresiliently flex against target tissue 370 and/or distal elements 318even after expanding the full range of the actuation angle 344.

Accordingly, in such embodiments, when the tissue gripper 316 is movedfrom the pre-deployed configuration toward the deployed configuration,the arms of the tissue gripper 316 abut against the target tissue 370and/or the distal elements 318 before reaching the full distal andoutward extension of the relaxed configuration. In this manner, the armsof the tissue gripper 316 can resiliently flex against the target tissue370 and/or distal elements 318 even after the tissue gripper 316 hasmoved the full or substantially full extent of the actuation angle 342.

In preferred embodiments, the tissue gripper 316, opening angle 340, andactuation angle 342 are configured such that when the tissue gripper 316moves toward a deployed configuration and engages with target tissue370, the tissue gripper 316 exerts a force of from 0.06 to 0.10 poundsagainst the target tissue 370. In other embodiments, the tissue grippercan exert a force of from 0.06 to 0.12 pounds or from 0.12 to 0.17pounds, for example.

FIG. 11C illustrates that, in some embodiments, following movement ofthe tissue gripper 316 toward a deployed configuration, the distalelements 318 may be closed or partially closed in order to move orposition the target tissue 370 and/or the components of the tissuegripping system 300 to a desired position and/or to assess the graspedtissue prior to further closing and release of the tissue grippingsystem 300. For example, the distal elements 318 can be actuated towarda closing angle 344 in order to move the distal elements 318 and thearms of the tissue gripper 316, as well as any target tissue 370 graspedtherebetween, into a closed position. In some embodiments, the closingangle 344 will be 60 degrees, or will range from 0 to 90 degrees (e.g.,0 to 30 degrees or 30 to 60 degrees or 60 degrees to 90 degrees). Inother embodiments, closing or partially closing the distal elements isomitted. For example, the tissue gripping system 300 or componentsthereof may be left in place or may be considered as properly positionedafter moving the tissue gripper 316 through the actuation angle 342,without additional closing of the tissue gripping system 300.

Various tissue gripping and/or tissue fixation procedures may call fordifferent closing angles 344 to be used. For example, a closing angle344 of 60 degrees or less may be useful in assessing the sufficiency ofa tissue grasping attempt in a mitral valve regurgitation procedure, anda closing angle 344 that is greater than 60 degrees (e.g., up to 180degrees) may be useful in a functional mitral valve regurgitationprocedure and/or in assessing the sufficiency of a tissue graspingattempt in a functional mitral valve regurgitation procedure.

IV. Methods of Manufacture

Embodiments of tissue gripping devices of the present disclosure may bemanufactured by forming a tissue gripper from a shape-memory material(such as nitinol), as illustrated in FIGS. 12A-12C. Forming the tissuegripper may be accomplished by cutting a pattern shape from ashape-memory stock material 450. The stock material 450 can be stripstock, sheet stock, band stock, or other forms of stock material.

The stock material 450 may be subjected to a subtractive manufacturingprocesses in order to prepare the stock material 450 with a suitablesize and shape prior to further manufacturing. For example, grinding ofone or more surfaces of the stock material 450 may be carried out inorder to achieve a desired dimension and/or a desired uniformity along agiven direction (e.g., grinding of a top and/or bottom surface toachieve a desired thickness).

As illustrated in FIG. 12B, various structural features (e.g., furcatedsections 420, holes 418, slotted recesses 432) may be formed in thestock material 450. This may be accomplished using any suitablesubtractive manufacturing process such as drilling, lathing, diestamping, cutting, or the like. In preferred embodiments, features areformed using a laser cut or wire-EDM process. For example, in preferredembodiments, a plurality of slotted recesses 432 are formed in the stockmaterial 450 using a laser cutting process. In some embodiments, otherfeatures may be added using an additive manufacturing process.

As illustrated in FIG. 12C, in some embodiments, the tissue gripper maybe further processed through a shape setting process. For example, oneor more bend features may be formed in the tissue gripper by subjectingthe tissue gripper to a heated shape setting process in order to set theshape of the bend(s) in the shape-memory material of the tissue gripper.For example, in embodiments including grippers formed from nitinol, theaustenite phase (i.e., parent phase or memory phase) can be set with thedesired bend features. In some embodiments, this requires positioningand/or forming the desired shape while heating the gripper to atemperature high enough to fix the shape as part of the austenite phase(e.g., 300 to 700 degrees C.).

For example, one or more of the base bend features 410, arm bendfeatures 412, and frictional elements 428 may be formed in a heat shapesetting process. In some embodiments, these features may be set at thesame time in one heat shape setting process. In other embodiments,multiple heat shape setting steps may be used, such as a first heatshape setting process to form the base bend features 410, followed by asecond heat shape setting process to form the arm bend features 412,followed by a third heat shape setting process to form the frictionalelements 428 (e.g., by bending portions of the side edge 430 adjacent toslotted recesses 432 in order to form distally and inwardly projectingbarbs). In yet other embodiments, other combinations of features may beset in any suitable number of heat shape setting steps in order to formthe tissue gripper 416.

In preferred embodiments, the arm bend features 412 are formed in a heatshape setting process such that the angle between the opposing arms 406,as measured from a proximal side 414 while the tissue gripper 416 is ina relaxed configuration, is 180 degrees or is slightly more than 180degrees (e.g., 185 to 200 degrees). In such embodiments, the tissuegripper 416 formed as a result of the manufacturing process can be movedinto a pre-deployed configuration by bending the arm bend features 412to move the arms 406 proximally and inwardly. In such a stressed state,the arms 406 will resiliently flex toward the relaxed configuration forthe full range of angles up to the relaxed configuration of 180 degreesor slightly more than 180 degrees. In addition, because the tissuegripper 416 is formed of a shape-memory material such as nitinol, and isconfigured to exhibit superelasticity at operational and physiologicaltemperatures, the arms 406 of the tissue gripper 416 are able to movefrom the relaxed configuration to the pre-deployed configuration withoutbeing plastically deformed, and are thus able to fully flex toward theoriginal relaxed configuration and return to the original relaxedconfiguration.

In some embodiments, one or more additional manufacturing processes maybe performed to prepare a tissue gripper 416. For example, mechanicaldeburring (e.g., small particulate blasting) and/or electropolishing(e.g., to clean edges and passivate the tissue gripper 416) may beperformed on the tissue gripper 416, or on parts thereof. Suchadditional processes may be done prior to, intermittent with, or afterone or more heat shape setting processes. In addition, the tissuegripper 416 may be cleaned in an ultrasonic bath (e.g., with DI waterand/or isopropyl alcohol, in combination or in succession).

V. Kits

Kit embodiments can include any of the components described herein, aswell as additional components useful for carrying out a tissue grippingprocedure. Kits may include, for example, a tissue gripping system asdescribed herein, including a tissue gripper, distal elements, actuatorrod, and actuator lines (such as lock lines and gripper lines), adelivery catheter, and a handle, the tissue gripping system beingcouplable to the delivery catheter at a distal end of the deliverycatheter and the handle being couplable to the delivery catheter at aproximal end of the delivery catheter. In such embodiments, the actuatorlines and/or actuator rod can pass from the tissue gripping systemthrough lumens of the delivery catheter and to the handle, and thehandle can include one or more controls for actuating or otherwisecontrolling the components of the tissue gripping system.

Some embodiments of kits may include additional interventional tools,such as a guidewire, dilator, needle, and/or instructions for use.Instructions for use can set forth any of the methods described herein.The components of the kit can optionally be packaged together in a pouchor other packaging, and in preferred embodiments will be sterilized.Optionally, separate pouches, bags, trays, or other packaging may beprovided within a larger package such that smaller packages can beopened separately to separately maintain the components in a sterilemanner.

The terms “approximately,” “about,” and “substantially” as used hereinrepresent an amount or condition close to the stated amount or conditionthat still performs a desired function or achieves a desired result. Forexample, the terms “approximately,” “about,” and “substantially” mayrefer to an amount that is within less than 10% of, within less than 1%of, within less than 0.1% of, and within less than 0.01% of a statedamount. In addition, unless expressly described otherwise, all amounts(e.g., temperature amounts, angle measurements, dimensions measurements,etc.) are to be interpreted as being “approximately,” “about,” and/or“substantially” the stated amount, regardless of whether the terms“approximately,” “about,” and/or “substantially.”

Additionally, elements described in relation to any embodiment depictedand/or described herein may be combinable with elements described inrelation to any other embodiment depicted and/or described herein. Forexample, any element described in relation to an embodiment depicted inFIGS. 9A-9C may be combinable an embodiment described in FIGS. 11A-11C.

The present disclosure may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the disclosure is, therefore,indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A tissue fixation kit, the kit comprising: adelivery catheter; and a tissue fixation system couplable to thedelivery catheter at a distal end of the delivery catheter, the tissuefixation system configured for intravascular delivery and for heartvalve tissue treatment, wherein the tissue fixation system includes: acenter portion defining a longitudinal axis, a distal element pivotallymoveable relative the longitudinal axis, and a gripper formed of ashape-memory material, wherein at least a portion of the gripper isconfigured to move relative to the distal element to capture nativevalve leaflet tissue therebetween, wherein the gripper includes: a bendconfigured to flex to allow the gripper to move relative to the distalelement, a furcated section having an opening defined therein, theopening including: a first end portion having a first maximumcross-dimension defined at a widest location within the first endportion, and a second end portion having a second maximumcross-dimension defined at a widest location within the second endportion, wherein the first maximum cross-dimension is different than thesecond maximum cross-dimension.
 2. The kit of claim 1, wherein theopening of the furcated section is fully enclosed.
 3. The kit of claim1, wherein the first end portion and the second end portion each have aterminal end.
 4. The kit of claim 1, wherein the second end portioncomprises curved opposing lateral edges.
 5. The kit of claim 1, whereinat least a portion of a length of the furcated section is within thebend.
 6. The kit of claim 1, wherein the second end portion is locatedcloser to the bend than the first end portion.
 7. The kit of claim 1,wherein the second maximum cross-dimension is greater than the firstmaximum cross-dimension.
 8. The kit of claim 1, wherein the second endportion comprises opposing lateral edges tapered towards the first endportion.
 9. The kit of claim 8, wherein the second end portion opposinglateral edges are curved.
 10. The kit of claim 8, wherein the second endportion has a radiused terminal end.
 11. The kit of claim 1, wherein thegripper further includes a barb section comprising at least one barb,wherein the furcated section is separate from the barb section.
 12. Thekit of claim 1, further comprising a handle couplable to the deliverycatheter at a proximal end of the delivery catheter.